Nazione: Canada
Lingua: inglese
Fonte: Health Canada
ACETAMINOPHEN; CODEINE PHOSPHATE; CAFFEINE
JANSSEN INC
N02AJ06
CODEINE AND PARACETAMOL
300MG; 30MG; 15MG
TABLET
ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG; CAFFEINE 15MG
ORAL
500
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0311391005; AHFS:
CANCELLED POST MARKET
2020-09-25
_242770 APM.docx _ _EDMS-RIM-101028v6.0 _ _Page 1 of 39 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N TYLENOL ® WITH CODEINE NO. 2 acetaminophen, caffeine and codeine phosphate tablets 300 mg acetaminophen, 15 mg caffeine and 15 mg codeine phosphate tablets N TYLENOL ® WITH CODEINE NO. 3 acetaminophen, caffeine and codeine phosphate tablets 300 mg acetaminophen, 15 mg caffeine and 30 mg codeine phosphate tablets Analgesic-Antipyretic Janssen Inc. 200 Whitehall Drive Markham, Ontario L3R 0T5 www.janssen.com/canada Date of Revision: September 17, 2020 SUBMISSION CONTROL NO: 242770 All trademarks used under license. © 2020 Janssen Inc. _242770 APM.docx _ _EDMS-RIM-101028v6.0 _ _Page 2 of 39 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................15 DRUG INTERACTIONS ..................................................................................................17 DOSAGE AND ADMINISTRATION ..............................................................................18 OVERDOSAGE ................................................................................................................21 ACTION AND CLINICAL PHARMACOLOGY ............................................................24 STORAGE AND STABILITY ..........................................................................................26 SPECIAL HANDLING INSTRUCTIONS ............................................................. Leggi il documento completo